MAUDE Adverse Event Report: CARDINAL HEALTH DA VINCI S PERMANENT CAUTERY HOOK; HOOK CAUTERY

Model Number 420183

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  Injury  

Event Description

The pt underwent an elective robotic cholecystectomy, with firefly icg cholangiogram for symptomatic cholelithiasis.While removing the gallbladder, the surgeon noted arcing of the hook cautery toward the liver, with unintentional cauterizing of the lever edge.No thermal injuries noted otherwise.The side of robotic hook was charred.

• Brand Name: DA VINCI S PERMANENT CAUTERY HOOK
• Type of Device: HOOK CAUTERY
• Manufacturer (Section D): CARDINAL HEALTH; dublin OH 43017
• MDR Report Key: 5441986
• MDR Text Key: 38424858
• Report Number: MW5060222
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183
• Device Lot Number: M10150126-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 64